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KOHJ-H-13-EN1-2.0-19042022
Appendices
Appendix 1: Carital Controllers - Guidance and Manufacturer’s Declarations – EMC
Electromagnetic Emissions (IEC 60601-1-2)
Emission Test
Compliance
Electromagnetic environment -
guidance
RF Emissions
CISPR 11
Group 1, Class B
Carital mattress systems are suitable
for use in all establishments including
domestic establishments
Harmonic
Emissions:
IEC 61000-3-2
Complies
Voltage
fluctuations/
flicker emissions:
IEC 61000-3-3
Complies
Electromagnetic Immunity (IEC 60601-1-2)
Emission Test
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact, ±2kV,
±4kV, ±8kV, ±15kV air
±8kV contact, ±2kV,
±4kV, ±8kV, ±15kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply
lines, ±1kV for input/
output lines
±2kV for power supply
lines, ±1kV for input/
output lines
Mains supply quality for the mains
adapter should be that of a typ-
ical commercial and/or hospital
environment.
Surge 61000-4-5
±0.5kV, ±1kV, ±2kV
Line-to-ground
±0.5kV, ±1kV, ±2kV
Line-to-ground
Mains supply quality for the mains
adapter should be that of a typ-
ical commercial and/or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UT; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle 70%
UT; 25/30 cycles
Single phase: at 0°
0% UT; 250/300 cycle
0% UT; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle 70%
UT; 25/30 cycles
Single phase: at 0°
0% UT; 250/300 cycle
Mains power quality should be that
of a typical commercial and/or hos-
pital environment. If the user of the
Carital mattress system requires con-
tinued operation during power mains
interruption, it is recommended that
the Carital controller is powered from
an uninterruptible power supply or
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30A/m
30A/m
Mains frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commer-
cial and/or hospital environment.
Note: Ur is the A.C. mains voltage prior to application of the test level.
Conducted RF
IEC 61000-4-6
3 Vrms (150 kHz to
80 MHz), 6 Vrms in
ISM bands between
150 kHz to 80 MHz
(80% AM at 1 kHz)
Portable and mobile RF communica-
tions equipment should not be used
closer than 30cm (12 inch) of Carital
controller, including cables. Using
portable and mobile RF communica-
tions equipment too close may result
Carital controller in not functioning
properly.
Interference may occur in the vicinity
of equipment marked with the follow-
ing symbol
Radiated RF
IEC 61000-4-3
10V/m (80 MHz to
2,7 GHz) and 20 V/m
(800 MHz to 2,5 GHz)
10V/m (80 MHz to
2,7 GHz) and 20 V/m
(800 MHz to 2,5 GHz)
Proximity fields
from RF wireless
communications
EQUIPMENT
IEC 61000-4-3
9V/m 710MHz, 745MHz,
780MHz, 5,240MHz,
5,500MHz and 5,785MHz
27V/m 385MHz
28V/m 450MHz, 810MHz,
870MHz, 930MHz,
1,720MHz, 1,845MHz,
1,970MHz and 2,450MHz
9V/m 710MHz, 745MHz,
780MHz, 5,240MHz,
5,500MHz and 5,785MHz
27V/m 385MHz
28 V/m 450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1970 MHz and 2450 MHz
